Events

Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-00002-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00002-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare has confirmed over-recovery of samples with concentrations greater than 5.5ng/ml (19.2nmol/l) with the immulite/immulite 1000 and immulite 2000/ immulite 2000 xpi androstenedione assays. siemens has determined that these lots are linear up to a concentration of 5.5ng/ml (19.2nmol/l), instead of 10ng/ml (34.9nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5ng/ml (19.2nmol/l) and 10ng/ml (34.9nmol/l) will detect this issue.
  • 조치
    Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.

Device

Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. ...
  • 모델명 / 제조번호(시리얼번호)
    Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000Catalogue Number: LKA01Siemens Material Number: 10381158Lot Number: 409 and aboveImmulite 2000/Immulite 2000XPiCatalogue Number: L2KA02Siemens Material Number: 10381188Lot Number: 314 and aboveARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division